Filing a New Registration for an Institutional Review Board (IRB) by an Institution or Organization (IORG)

Alert: Before continuing on this page please be aware that this area should ONLY be used if your institution or organization has never been assigned an IORG number by OHRP and never registered an IRB.

Introduction

You must register your institution’s or organization’s IRB(s) using this electronic submission system unless your institution or organization lacks the ability to registry its IRB electronically.

An IRB registration is effective for 3 years; however, when information changes regarding the contact person who provided the IRB registration information or the IRB chairperson,an update/renewal must be submitted to OHRP within 90 days after the changes occur. After processing the initial registration, any update/renewal to the registration information on your institution's or organization's IRB also must be done electronically through the electronic submission system, unless your institution or organization lacks the ability to register an IRB electronically.

Using this web page, your institution or organization can register an IRB if your institution or organization has never been assigned an IORG number by OHRP and never registered an IRB. We recommend that you print out and have available the instructions for registering an IRB(s) at http://www.hhs.gov/ohrp/assurances/irb/register/index.html.

Additional instructions for electronic submission of a new IRB registration are provided below:

You must have an e-mail address in order to use the electronic submission process. You will start the electronic submission process at the bottom of the screen.

You will need to be sure all required () fields are completed.

Once you have entered information on each screen and proofread all data fields, click on the "Save and Continue" button to move to the next section.

You may use the tab at the top of the page for quickly moving from section to section of the IRB registration form. However, please be aware that if you have not saved information on a page before going to another page, you will lose the information you entered on the last screen.

Once all entries are made, please proofread all fields of the IRB registration form and roster(s) - if a roster is required - to ensure the accuracy of the data and then click "Submit." Once all required fields are completed, you will be prompted to add the missing information. If not, you will be prompted to print a copy of your submission for your record.

Once you "Submit" the electronic registration for your institution’s or organzation’s IRB(s), the first phase of the registration process is complete. OHRP will receive your electronic request and process it as soon as possible.

Note: You may begin entering registration information for an electronic submission and then find you are not ready to "Submit" it to OHRP for review. In this case, you may save the data entered and return at a later time to complete the submission. Be sure you have recorded your submission number for later use.

With the electronic submission process, the submitter, the IRB Chairperson(s), and the Institution or Organization (IORG) Head Official/Senior Officer who is responsible for overseeing activities performed by the IRB will be notified automatically by e-mail as soon as OHRP has processed your submission. Of course, this is dependent upon correct e-mail addresses being provided for each of these individuals.

Note: You must request a submission number for each separate electronic IRB registration you submit to OHRP. The submission number is only good until OHRP processes the IRB registration associated with that submission. After processing of an electronically submitted IRB registration, you must request a new submission number for subsequent electronic updates/renewals. Also, please do not attempt to update/renew an IRB registration when there is already an electronic record being processed by OHRP. The changes you request with each electronic submission are not transferred to OHRP's database until the IRB registration has been processed. When the IRB registration is processed, you will receive an e-mail notification.

Submit a new IRB Registration

If you need a submission number to begin a new IRB registration, click on “I Need a Submission Number” below.

Note: if you do not use the submission number within 30 days, it will be withdrawn from the system, and you will have to request a new submission number if you want to begin a new IRB registration.

Continue a new IRB Registration that was started but not submitted

If you previously began data entry, and are now ready to edit further and/or submit your new IRB registration, click on the “I Have a Submission Number” below.

Note: if you do not return to complete your submission within 30 days, it will be withdrawn from the system, and you will have to request a new submission number and begin entering all of the data again.

Forgot Your Submission Number and/or Password

If you started the electronic entry for the registration of your institution’s or organization's IRB(s) but can't remember your submission number and/or your password, enter the e-mail address where your submission number was sent.